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Sensory Testing and Brain Imaging for Menstrual Cramps
Study Summary
This trial will explore the connection between brain function, pain inhibition, and chronic pain in adolescent girls.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have been diagnosed with a psychotic disorder in the past or present.You use alcohol, cannabis, or other illegal drugs every week.Your body mass index (BMI) is 35 or lower.I am a female between 13 and 19 years old.I have a condition like autism that might make it hard for me to understand the study.I experience pelvic pain all month, not just during my period.You have metal braces, retainers, or implants that can't be used with the MRI machine.You have had normal periods for at least 6 months.You use your right hand for tasks.I have access to a smartphone or email.Your periods usually come every 22 to 35 days.I haven't used oral contraceptives or hormones in the last 3 months.I don't have any recent illnesses or injuries that could affect my pain sensitivity or performance in tasks.I am currently experiencing severe depression, bipolar disorder, panic disorder, or ADHD, or am being treated for these.You are very scared of small, enclosed spaces.I have been diagnosed with a chronic pain condition like IBS.I have had pelvic inflammatory disease or an STD in the past.I haven't used stimulants or opioids in the last 3 months.My parent can give written permission for me to participate.I was diagnosed with an eating disorder in the last 6 months.
- Group 1: fMRI and laboratory pain induction
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Have enrollment opportunities arisen for this experiment?
"On clinicaltrials.gov, this research is still accepting participants. Initially listed on December 14th 2020 and amended August 2nd 2022, the study needs volunteers to proceed."
Am I a qualified participant for this trial?
"For this clinical trial, 212 adolescent females between the ages of 13 and 19 suffering from primary dysmenorrhoea are being accepted. These patients must meet a few eligibility requirements including; self-reported menstrual cycles averaging 22 to 35 days spanning at least 6 months, access to a smartphone or email account, right handedness, Body Mass Index (BMI) under 35, fluency in English , consent/assent form filled out by both patient and parent if applicable, and more."
Are individuals who are 20 years or older eligible to participate in this investigation?
"This trial has set the age range for enrollment between 13 and 19. There are 5 trials open to those under 18, while 6 studies are available for patients over 65 years old."
How many participants are allowed to be involved in this investigation?
"Affirmative. According to clinicaltrials.gov, this medical investigation is actively looking for candidates; it has been advertised since December 14th 2020 and was most recently edited on August 2nd 2022. The trial requires the enrolment of 212 participants from a single location."
What is the main intent behind this clinical experiment?
"The primary objective of this trial, monitored over the baseline period, is to measure white matter fibre tract values. Secondary objectives include assessing alterations in pain inhibition via changes in conditioned pain modulation (CPM) from Baseline to 12-months post baseline; investigating region-to-region connectivity strength between salience, sensorimotor, emotional arousal and default mode networks during resting states; and measuring changes in menstrual pain ratings on a 0 (no pain) - 10 (worst possible pain) scale from 12 months post Baseline to 24 months post Baseline."
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